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NCT07700524

Intraoperative Ultrasound Assessment of Coronary Artery and Bypass Graft Blood Flow During CABG

Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

View on ClinicalTrials.gov

Summary

This single-centre, prospective observational feasibility and safety study will enrol 190 consecutive adults undergoing elective isolated coronary artery bypass grafting (CABG) at Nanjing Drum Tower Hospital. The study aims to evaluate the feasibility and safety of intraoperative ultrasound for the quantitative assessment of native coronary artery and bypass graft blood flow. Transit-time flow measurement will be performed as part of routine intraoperative graft assessment. Additional ultrasound measurements will be obtained from major native coronary arteries before and after revascularisation and from bypass grafts after restoration of blood flow. The ultrasound findings will be collected for research purposes and will not influence graft revision or other intraoperative clinical decisions. The co-primary outcomes are the participant-level technical success rate of the protocol-defined intraoperative ultrasound assessment and the incidence of adverse events related to the ultrasound device or measurement procedure. Secondary outcomes include agreement between ultrasound and transit-time flow measurements, changes in native coronary artery blood flow after revascularisation, measurement repeatability, and exploratory associations between intraoperative flow parameters and postoperative cardiac function and myocardial injury biomarkers. Participants will be followed for 30 ± 7 days after surgery.

Official title: Quantitative Assessment of Native Coronary Artery and Bypass Graft Blood Flow Using Intraoperative Ultrasound in Patients Undergoing Coronary Artery Bypass Grafting: A Single-Centre Prospective Feasibility and Safety Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

190

Start Date

2027-01-01

Completion Date

2029-12-30

Last Updated

2026-08-11

Healthy Volunteers

Conditions

Coronary Artery Disease

Interventions

DIAGNOSTIC_TEST

Intraoperative Ultrasound Blood Flow Measurement

Intraoperative ultrasound measurements of major native coronary arteries will be obtained before and after revascularisation, followed by measurements of individual bypass grafts after restoration of blood flow. Recorded variables will include blood flow velocity, volumetric blood flow and other protocol-defined quantitative parameters. The findings will be collected for research purposes and will not guide graft revision or other intraoperative clinical decisions.

Inclusion Criteria: * Aged 18 years or older. * Confirmed coronary artery disease and scheduled to undergo elective isolated coronary artery bypass grafting at Nanjing Drum Tower Hospital. * Able and willing to provide written informed consent before any study-specific procedures are performed. Exclusion Criteria: * Urgent, emergency, or salvage coronary artery bypass grafting. * Prolonged preoperative fasting, as defined in the study protocol, or inability to maintain adequate oral intake without enteral or parenteral nutritional support. * History of malignancy. * Body weight below 50 kg. * Preoperative hemodynamic instability requiring ongoing resuscitation or mechanical circulatory support, including intra-aortic balloon pump, extracorporeal membrane oxygenation, or left ventricular assist device support. * Endotracheal intubation and invasive mechanical ventilation before surgery. * Impaired consciousness, clinically significant central nervous system dysfunction, or evidence of cerebral malperfusion after hospital admission. * End-stage renal disease requiring maintenance dialysis before hospital admission. * Severe pulmonary disease considered to preclude tolerance of elective coronary artery bypass grafting or to confer an unacceptably high perioperative risk. * Severe peripheral vascular disease or clinical evidence of limb malperfusion before surgery. * History of gastrointestinal ulceration or chronic inflammatory gastrointestinal disease. * Chronic inflammatory or autoimmune disease, or long-term treatment with systemic corticosteroids or non-steroidal anti-inflammatory drugs. * Active infection or sepsis at screening. * Severe uncontrolled arrhythmia requiring urgent treatment or expected to cause marked intraoperative hemodynamic instability. * Previous cardiac surgery requiring repeat median sternotomy. * Planned concomitant major cardiac or aortic surgery, including valve surgery, congenital heart defect repair, or aortic surgery. * Inability to understand the study information or unwillingness or inability to provide written informed consent. * Inability or unwillingness to complete follow-up at 30 ± 7 days after surgery. * Pregnancy or breastfeeding.

Locations (1)

Nanjing Drum Tower Hospital, Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China